Pifeltro

RSS

doravirine

Authorised
This medicine is authorised for use in the European Union.

Overview

Pifeltro is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Pifeltro is used together with other antiviral medicines.

The medicine is not suitable for patients who are infected with HIV that is resistant to medicines in the same class as Pifeltro (non-nucleoside reverse transcriptase inhibitors or NNRTIs).

Pifeltro contains the active substance doravirine.

This EPAR was last updated on 25/11/2019

Authorisation details

Product details
Name
Pifeltro
Agency product number
EMEA/H/C/004747
Active substance
Doravirine
International non-proprietary name (INN) or common name
doravirine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AG06
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
22/11/2018
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

13/11/2019 Pifeltro - EMEA/H/C/004747 - IB/0008

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class.

Assessment history

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